Kornimate/medical-research-clean huggingface dataset:
multimodal ophthalmic imaging and plasma biomarkers for the early detection of alzheimer's disease

Conditions: Alzheimer&#39;s Disease (AD)

Summary: with the accelerating global aging population, dementia has become a pressing worldwide issue. this project aims to identify specific plasma biomarkers and ocular indicators for the early detection of alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * male or female participants aged ≥ 50 years; * participants diagnosed with alzheimer's disease (ad), mild cognitive decline (mci), subjective cognitive decline (scd), or cognitively normal (cn); * signed informed consent form exclusion criteria: * presence of other neurological disorders and systemic diseases that may cause cognitive impairment; * inability to cooperate with cognitive assessments; * refusal to undergo blood sampling.
vnrx-5133 sad/mad safety and pk in healthy adult volunteers

Conditions: Bacterial Infections

Summary: this is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of vnrx-5133 administered via intravenous (iv) infusion in healthy subjects. in part 1, subjects will receive a single dose of vnrx-5133; in part 2 subjects will receive vnrx-5133 for 7 days.


Eligibility criteria:
inclusion criteria: * healthy adults * males or non-pregnant, non-lactating females * body mass index (bmi) between 18.5 - 32.0, inclusive. * suitable veins for cannulation exclusion criteria: * employee of site or the sponsor * any disease that poses an unacceptable risk to participants * abnormal ecg * abnormal labs * abnormal vital signs * current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder * positive serology for hepatitis b surface antigen, hepatitis c antibody, or human immunodeficiency virus (hiv) type 1 * current smokers or history of smoking within 30 days

Keywords: healthy volunteers pharmacokinetics
comparing arni and ace for improving erectile dysfunction in men with reduced ejection fraction heart failure

Conditions: Heart Failure; Heart Failure, Systolic; Erectile Dysfunction

Summary: the purpose of this study was to determine the effect of sacubitril/valsartan (lcz696) vs. enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.

the purpose of this study was to evaluate the effect of sacubitril/valsartan in improving erectile function in male patients with chronic heart failure (nyha ii) and reduced ejection fraction (hfref) and erectile dysfunction (ed). data from this study was intended to provide a thorough understanding of the impact of sacubitril/valsartan on male sexual function and therefore quality of life.

Eligibility criteria:
key inclusion criteria: * patients with a diagnosis of chronic heart failure (nyha class ii) and reduced ejection fraction (lvef \< 40%) * patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start * patients must have a mild to moderate erectile dysfunction (determined by using the iief-5 questionnaire) * patients must be on an acei or an arb at a stable dose for at least 4 weeks prior study start * patients must be literate in german key exclusion criteria: * history of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, aceis, arbs or nep inhibitors, as well as known or suspected contraindications to the study drugs * previous history of intolerance to recommended target doses of aceis or arbs * known history of angioedema * current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy) * symptomatic hypotension * impaired renal function * penile anatomical defects and peyronie's disease * diabetes mellitus type i or insulin-dependent type ii * known prostate cancer

Keywords: heart failure systolic heart failure heart failure with reduced ejection fraction erectile dysfunction enalapril enalaprilat lcz696 sacubitril/valsartan
rlip76 in human serum in adults with rheumatologic diseases

Conditions: Carotid Atherosclerosis

Summary: it is the investigators aim to determine the feasibility of directly detecting anti-rlip76 auto-antibodies in human serum using prepared rlip76 antigen peptides in persons with rheumatologic disease and persons without rheumatologic diesease ("healthy subjects").

this is an exploratory study conducted to see the feasibility of measuring the anti-rlip76 antibody and to standardize the methods for its measurement. we will perform these studies on blood samples obtained from human subjects after informed concent for blood draw for research purposes is obtained by the clinical research co-ordinator (crc).

Eligibility criteria:
inclusion criteria: * adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study. exclusion criteria: * children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.

Keywords: rlip76 auto antibodies
dermabond treatment for gastric variceal bleeding

Conditions: Gastric Varices

Summary: the purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by indiana university eus physicians; specifically, for the treatment of gastric variceal bleeding this data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. the physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

clinical outcomes research is one of the strengths of the eus group. as a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the united states.

Eligibility criteria:
inclusion criteria: anyone receiving treatment with dermabond for treatment gastric varices. exclusion criteria: no evidence of gastric varices. -
pretreatment assessment of oropharynx ans soft palate radiofrequency surgery - a multi-center study

Conditions: Snoring

Summary: interstitial radiofrequency (rf) surgery of the soft palate (sp) is an established option in the treatment of habitual snoring. the decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. the aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial rf surgery of sp in a multi-center study

table 1. the inclusion and exclusion criterion used for the multicenter study. criteria inclusion exclusion _____________ age (years) 18-65 \ 65 habitual snoring yes no excessive daytime sleepiness no yes bmi (kg/m2) \ 28 ahi (events/hour) \ 15 overjet (mm) \ 5 clinical suspicion of obstruction no yes at base of tongue size of palatine tonsils (grade) 0-ii iii-iv nose breathing problems no yes pharyngeal tonsil hypertrophy no yes a bed partner to assess snoring yes no _____________ abbreviations: bmi = body mass index, ahi = apnea-hypopnea index.

Eligibility criteria:
table 1. the inclusion and exclusion criterion used for the multicenter study. criteria inclusion exclusion _____________ age (years) 18-65 \ 65 habitual snoring yes no excessive daytime sleepiness no yes bmi (kg/m2) \ 28 ahi (events/hour) \ 15 overjet (mm) \ 5 clinical suspicion of obstruction no yes at base of tongue size of palatine tonsils (grade) 0-ii iii-iv nose breathing problems no yes pharyngeal tonsil hypertrophy no yes a bed partner to assess snoring yes no _____________ abbreviations: bmi = body mass index, ahi = apnea-hypopnea index.

Keywords: radiofrequency, ablation, rfa, rfta, rfitt, soft palate.
gentamicin for junctional epidermolysis bullosa

Conditions: Junctional Epidermolysis Bullosa

Summary: herlitz junctional epidermolysis bullosa (h-jeb), an incurable, fatal, inherited skin disease, is caused by loss-of-function mutations in the lama3, lamb3 or lamc2 genes, resulting in loss of laminin 332 and poor epidermal-dermal adherence. eighty percent of h-jeb patients have lamb3 mutations and about 95% of these are nonsense mutations. the investigators recently demonstrated that gentamicin readily induced nonsense mutation readthrough and produced full-length laminin beta3 in several nonsense mutations tested. importantly, the gentamicin-induced laminin beta3 restored laminin 332 assembly, secretion, and deposition into the dermal-epidermal junction (dej). newly induced laminin 332 reversed abnormal h-jeb cellular phenotypes. herein, the investigators propose the first clinical trial of gentamicin (by topical and intravenous administration) in jeb patients with nonsense mutations. the milestones will include restored laminin 332 and hemidesmosomes at the dej, improved wound closure, and the absence of significant gentamicin side effects.

three subjects (adults and children of any age) will receive topical gentamicin to be applied to select skin sites. three subjects (adults and children of any age) will receive intravenous (iv) gentamicin infusions. patients will be assessed for primary and secondary endpoints during follow up visits.

Eligibility criteria:
inclusion criteria: 1. jeb patients with nonsense mutations in the lamb3 gene in either one or two alleles. exclusion criteria: 1. jeb patients who do not have nonsense mutations in the lamb3 gene in either allele. 2. pre-existing known auditory impairment. 3. pre-existing known renal impairment. 4. pre-existing known allergies to aminoglycosides or sulfate compounds. 5. pregnancy.

Keywords: herlitz laminin 332 laminin beta 3 jeb
telotristat etiprate for carcinoid syndrome therapy

Conditions: Carcinoid Syndrome

Summary: the purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-hiaa) levels.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * all patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the follow-up visit. * histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor * documented history of carcinoid syndrome * patient is able and willing to provide written informed consent prior to participation exclusion criteria: * presence of diarrhea attributed to any condition other than carcinoid syndrome. * presence of 12 or more watery bowel movements per day * positive stool examination for enteric pathogens, pathogenic ova or parasites, of clostridium difficile at screening * karnofsky performance status ≤ 60% * presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the investigator * a history of short bowel syndrome * history of constipation within 2 years of screening * life expectancy \< 12 months from screening
clinical outcomes of the implementation of diurnal iop curve to 1500 patients - a cohort study.

Conditions: To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice

Summary: to present the clinical outcomes of diurnal iop monitoring and determine its value in our clinical practice.we reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years.

we reviewed the records of 1500 patients, who were admitted for diurnal curve during almost 12 years. all patients were hospitalized because their within office-hours exams were considered inadequate and inconclusive for decision-making 744 patients needed change of treatment. 121 patients were programmed for interventional therapy (laser or surgery). 68 patients were declassified, as overdiagnosed and overtreated. in 250 patients hidden adherence problem revealed. in 720 patients peak iop occurred out of office hours.

Eligibility criteria:
inclusion criteria: iop diurnal curve consisted of glaucoma patients with intraocular pressure higher than target pressure despite referred previously sufficient therapy and also patients with equal or lower than target pressure, but with disease progression. there were also included patients with advanced glaucoma with visual field defects on the visual field testing, as well as patients with normal tension glaucoma and labile secondary glaucomas (exfoliative, pigmentary and chronic angle closure glaucoma), for whom close monitoring and therapy reconsidering was judged appropriate.glaucoma suspects, demonstrating findings consistent with increased risk for glaucoma development, were included. - exclusion criteria: patients with missing data values for iop -

Keywords: tonometric curve, diurnal iop, iop phasing, iop monitoring, glaucoma, glaucoma suspects, iop peaks, hypertension, compliance, adherence,
mobile and digital application in heart failure networks berlin/brandenburg

Conditions: Heart Failure

Summary: the mobidig trial is designed to evaluate an implementation of a mobile phone application with secondary preventive/rehabilitative modules for patients with heart failure in certified heart failure unit centers in berlin and brandenburg. the aim is to evaluate the effect on quality of life, symptoms and the course of the disease. in addition, the acceptance, adherence and user behavior as well as the implementation potential for a permanent introduction of the application in national heart failure networks will be analyzed.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of heart failure * treatment in a certified heart failure unit center in berlin or brandenburg * written informed consent of the participants * user of a mobile device with an ios operating system exclusion criteria: * addiction or other illnesses that do not allow the participants to assess the nature and scope as well as possible consequences of participation or its scientific evaluation * insufficient knowledge of the german language, which is necessary to use the application
can immediate post-injury fluoxetine improve the recovery trajectories of victims in bodily trauma?

Conditions: Musculoskeletal Injury

Summary: with this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with fluoxetine will prevent/mitigate the development of negative psychiatric symptomology such as ptsd and depression for victims of bodily trauma. we also hypothesize that immediate use of fluoxetine will decrease subjects' pain, pain interference and opioid use without changing our standard of care post-injury pain medication regimen. enrolled subjects will be randomized to fluoxetine or placebo at their index hospitalization.

upwards of 40-85% survivors of bodily trauma (in the civilian world most commonly motor vehicle accidents, falls and assaults), develop moderate to severe negative psychiatric symptomology following their injuries. (2,7) this symptomology can persist for years; at least 20% of patients with musculoskeletal trauma, specifically, display symptomology consistent with post-traumatic stress disorder (ptsd) symptomology up to three years following their injury. (8) poor mental health outcomes are an independent risk factor for poor physical and social outcomes. (9,10) these symptoms, which are highly impairing, are complicated and heightened by loss of work/income following trauma, limited financial and social resources, and a large percentage of the population being uninsured/underinsured. research has demonstrated that the pressures of poverty and low socioeconomic status alone predispose to ptsd symptomology and poor coping mechanisms, and this is compounded by decreased ability to obtain and pay for mental health care by those impoverished. there are significant barriers to mental health care for many adults, and these hurdles are even more insurmountable for those under or uninsured, minorities, and those in rural communities. (11) very few victims of trauma who screen positive for psychological disorder receive mental health services following injury (12% at 3-months from injury), and if so, it is far removed from the injury (22% at 24-months from injury).

Eligibility criteria:
inclusion criteria: * admitted to uf health for trauma resulting in: * one or more extremity fractures requiring surgery * pelvic fracture * chest/abdominal injury requiring intervention in operating room * polytrauma (multiple organ systems/multiple fractures) or beck depression inventory (bdi-ii) ≥ 14 exclusion criteria: * severe traumatic brain injury or cognitively not able to participate in surveys. (glasgow coma scale 3-8) * other psychiatric conditions on current medical management (ssri) * incarceration or pregnancy * expected injury survival of less than 90 days * medical or physical condition in opinion of investigators that would preclude safe study participation * unable to provide informed consent due to language or other barriers * current or previous substance abuse (excluding cannabinoids and alcohol)
study of pembrolizumab, radiation and immune modulatory cocktail in cervical/uterine cancer

Conditions: Cervical Cancer; Endometrial Cancer; Uterine Cancer

Summary: this is a phase ii study in patients with advanced and/refractory cervical cancer, endometrial carcinoma or uterine sarcoma. patients will be treated with an immunomodulatory cocktail (vitamin d, aspirin, cyclophosphamide and lansoprazole), followed by pembrolizumab, combined with radiation. in addition, patients will take curcumin, a food supplement.

this is a phase ii multi-center, open-label, non-randomized, 3-cohort study in patients with advanced and/or refractory cervical cancer, endometrial carcinoma or uterine sarcoma. patients will be treated by an immunomodulatory cocktail (consisting of a daily intake of 2000 iu vitamin d, 325 mg aspirin, 50 mg cyclophosphamide and 180 or 30 mg lansoprazole alternating weekly), followed by pembrolizumab administered intravenously at 200 mg in 21-day treatment cycles, combined with radiation (3x 8gy in 48h-intervals). in addition, patients will take curcumin, a food supplement on a daily basis.

Eligibility criteria:
inclusion criteria: * have histologically confirmed endometrial carcinoma, cervical carcinoma or uterine sarcoma, refractory or persistent to chemotherapy or recurrent disease after at least one line of chemotherapy. * presence of an index lesion amenable to hypofractionated stereotactic radiotherapy * at least one lesion outside the radiation field that can be followed by imaging for clinical response according to recist and irrc * be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion before and after radiotherapy if technically feasible. * have a performance status of 0 or 1 or 2 on the ecog performance scale. * demonstrate adequate organ function exclusion criteria: * currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * prior treatment with anti-pd-1, anti-pd-l1, anti-pd-l2 agent * diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of trial treatment, * known history of active tb (bacillus tuberculosis), human immunodeficiency virus (hiv), htlv or syphilis,non-infectious pneumonitis, has active autoimmune disease. * has active central nervous system metastases and/or carcinomatous meningitis

Keywords: immunotherapy radiotherapy immune-modulatory cocktail
chest dysphoria in transmasculine spectrum adolescents

Conditions: Gender Dysphoria

Summary: the investigators hypothesize that masculinizing top surgery (e.g., mastectomy and chest masculinization) leads to an improvement in self-report chest dysphoria, gender dysphoria, and gender congruence in assigned-female-at-birth, transgender and non-binary youth and young adults. this is a prospective, observational study that will enroll assigned-female-at-birth, transmasculine spectrum individuals age 13 to 25 years old who are or are not undergoing top surgery. participants will complete a set of standard of care questionnaires regarding their chest dysphoria (e.g., distress about the chest), gender dysphoria (e.g., distress about a gender identity that does not match assigned sex), and gender congruence (e.g., degree to which an individual feels they are living in their authentic appearance and gender identity). they will complete this same set of questionnaires either three months after their top surgery or three months after the initial set of surveys.


Eligibility criteria:
inclusion criteria: * assigned the female sex at birth * affirmed gender identity of male, non-binary, or gender other than female * english-speaking * undergoing top surgery or matches a top surgery participant on age and number of months on testosterone exclusion criteria: * non english speaking * unable to complete self-report questionnaires
tricuspid regurgitation risk model study (trail study)

Conditions: Tricuspid Regurgitation

Summary: this study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. the primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events. the prognostic risk factors of patients with tricuspid regurgitation are evaluated, and the prognostic models are constructed through the follow-up observation.


Eligibility criteria:
inclusion criteria: * aged over 18 yrs. * patients diagnosed with tricuspid regurgitation during hospitalization. exclusion criteria: * patients unable to provide informed consent.

Keywords: tricuspid regurgitation all-cause mortality risk factor prediction model